Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 100 mg dose of [14C] GLPG0634

Study type: Interventional

Funder types: Industry

Identifiers

NCT01820806

GLPG0634-CL-105

Details and patient eligibility

About

This will be a study in 6 healthy male subjects, each receiving a single oral dose of 100 mg [14C]-radiolabeled GLPG0634.

The study aims to establish the elimination pathways of GLPG0634 and their relative significance and to assess the metabolite profile of GLPG0634 in plasma and in excreta.

Furthermore, the pharmacokinetics (PK) of the main metabolites in plasma relative to GLPG0634 will be evaluated.

This study will also provide safety and tolerability information for GLPG0634.

Enrollment: 6 patients

Sex: Male

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• male, between 40 and 65 years of age, inclusive
• within BMI range 18 to 30 kg/m2, inclusive

Exclusion criteria

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

[14C] GLPG0634

Experimental group

Description:

Subjects will be dosed with a single oral 100 mg dose of \[14C\] GLPG0634 on one occasion

Treatment:

Drug: 100 mg dose of [14C] GLPG0634